clindamycin-phosphate and Erythema

OBJECTIVE: To evaluate long-term efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (Clindamycin-BP 3.75%) aqueous gel in adult female patients with moderate acne vulgaris.

METHODS: Total of 20 patients, 25-63 years of age (mean [SD], 38 ± 10) with moderate acne (IGA=3) were treated with Clindamycin-BP 3.75% once-daily for 12 weeks. Patients who experienced ≥50% reduction in total lesion count continued treatment for a further 12 weeks. Mean (SD) percent reduction in lesion counts from baseline were assessed at week 4, 8, 12, 18, and 24. In addition, patients who were 'clear' or 'almost clear' were reported at week 12 and 24. Cutaneous tolerability (erythema, dryness, peeling, pruritus, and burning) and oiliness was assessed at baseline and each study visit. Adverse events were assessed throughout the study.

RESULTS: Clindamycin-BP 3.75% demonstrated statistical significant improvement from baseline and between each visit. At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts was 70.6% and 58.6%, respectively. Two patients failed to experience ≥50% lesion reduction by week 12. At week 24, mean percent reductions in inflammatory and noninflammatory lesion counts were 93.8% and 90; 72% of patients were 'clear' or 'almost clear'. Overall the treatment was tolerable. There was one adverse event (sinus infection) that was not treatment-related.

CONCLUSIONS: Clindamycin-BP 3.75% gel demonstrates continued improvement in symptoms of moderate acne over 24 weeks, with good tolerability, demonstrating a clinical benefit of continued clindamycin-BP 3.75% gel as a maintenance therapy for acne in adult female patients.

J Drugs Dermatol. 2017;16(6):543-546.

Topics: Acne Vulgaris; Administration, Cutaneous; Adult; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Double-Blind Method; Drug Combinations; Erythema; Female; Gels; Humans; Middle Aged; Patient Satisfaction; Treatment Outcome

Epidermal growth factor receptor inhibitors are recent antineoplastic treatments used for the treatment of some non-cutaneous tumours, which aberrantly express EGFR. Because of their specificity, these drugs have low systemic toxicity, but frequent undesired cutaneous effects, the most common of which is an acneiform eruption, occurring after 1-3 weeks of treatment. Management of this rash is not well standardized.. We evaluated efficacy, tolerability and impact on quality of life of a clindamycin phosphate 1.2%-benzoyl peroxide 5% gel in 12 male adults who developed acneiform eruption during treatment with cetuximab for metastatic colorectal cancer.. Patients applied the clindamycin phosphate-benzoyl peroxide gel once daily, at evening, for 8 weeks. The Skin-Score was used to evaluate reduction of erythema, papules, pustules and pruritus, the Dermatology Life Quality Index questionnaire to evaluate the improvements of health-related quality of life.. Significant clinical improvements occurred after 2 weeks of treatment and were even more evident after 8 weeks (mean Skin-Score 20.54 ± 7.83, p = 1.37 × 10(-6) vs. second week visit, p = 1.26 × 10(-7) vs. before treatment). Accordingly, DLQI values decreased from 13.64 ± 2.01 before treatment to 6.45 ± 1.37 after 8 weeks (p = 1.12 × 10(-5)).. A clindamycin phosphate-benzoyl peroxide gel may be an effective and safe option in the treatment of cetuximab-associated acneiform eruptions.

Topics: Acneiform Eruptions; Administration, Cutaneous; Aged; Anti-Bacterial Agents; Antineoplastic Agents; Benzoyl Peroxide; Cetuximab; Clindamycin; Colorectal Neoplasms; Erythema; Follow-Up Studies; Gels; Humans; Male; Middle Aged; Pruritus; Quality of Life

A fixed-dose combination of clindamycin phosphate 1.2% and tretinoin 0.025% gel (VELTIN® (clindamycin phosphate and tretinoin) 1.2%/0.025% Gel [VELTIN]) (clindamycin/tretinoin gel) is currently available for the once-daily topical treatment of acne.. Two-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel.. Study 1 (phototoxic) (n=37) and Study 2 (photoallergic) (n=58) were single-center, evaluator-blinded, randomized, vehicle-controlled, phase 1 studies conducted in healthy volunteers. In Study 1, clindamycin/tretinoin gel patches, vehicle gel patches and blank patches (no gel) were applied concurrently for 24 hours to naïve sites. After patch removal, sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) then 0.75 minimal erythema dose (MED) of UVA/ultraviolet B light (UVB), the same irradiation protocol followed by 15 joules/cm2 of visible light (VIS), or served as non-irradiated controls. Study 2 examined the effect of repeated drug exposure and involved an induction period (6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours, removed and sites irradiated with UVB +/- VIS), followed by a rest period (10 to 17 days), then a challenge period that used the protocol described for Study 1. In both studies, inflammatory responses and other cutaneous effects were evaluated at 1, 24, 48, and 72 hours after patch removal.. No subject experienced any adverse events in Study 1 (phototoxic). One subject in Study 2 (photoallergic) experienced AEs (diffuse erythema; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites) considered definitely related to study product that resulted in discontinuation from the study. Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation.. Clindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity.

Topics: Acne Vulgaris; Administration, Cutaneous; Adolescent; Adult; Aged; Anti-Bacterial Agents; Clindamycin; Dermatitis, Photoallergic; Dermatitis, Phototoxic; Drug Combinations; Erythema; Female; Humans; Keratolytic Agents; Male; Middle Aged; Treatment Outcome; Tretinoin; Young Adult